MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. XTEND; XTEND ANTERIOR CERVICAL PLATE, 2-LEVEL, 32MM

Model Number	161.232
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screws in a xtend plate were found to be backing out post-operatively.
Additional Manufacturer Narrative
The screw was not returned, nor was the lot number listed.Additional information provided.Dr.(b)(6) has a unique technique, he doesn't use a drill guide, he burrs first and then inserts the screws.He may not have put the screw in.This evaluation determined that this failure was within the expected risk.Therefore, no further actions will be taken at this time.If further information is provided, this complaint can be reopened in the future.

• Brand Name: XTEND
• Common Device Name: XTEND ANTERIOR CERVICAL PLATE, 2-LEVEL, 32MM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 23038599
• Report Number: 3004142400-2025-00215
• Device Sequence Number: 9477110
• Product Code: KWQ
• UDI-Device Identifier: 00849044087956
• UDI-Public: 00849044087956
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K092146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 161.232
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown